510(k) K210633
K210633 is an FDA 510(k) premarket notification submitted by Abbott Ireland Diagnostics Division for the device "Amylase2". The FDA issued a decision of Substantially Equivalent on May 26, 2022. The device falls under product code JFJ (Catalytic Methods, Amylase), a Class II device regulated under 21 CFR 862.1070. Abbott Ireland Diagnostics Division has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 2022
- Date Received
- March 3, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catalytic Methods, Amylase
- Device Class
- Class II
- Regulation Number
- 862.1070
- Review Panel
- CH
- Submission Type